Evaluation of the Solvent Evaporation Time of Universal Adhesives in the Quality of Cervical Lesions Restorations

July 11, 2023 updated by: Mario Felipe Gutiérrez Reyes, Universidad de los Andes, Chile

Clinical Evaluation of the Effect of the Prolonged Evaporation Time of the Solvent of Two Universal Adhesives in Restorations of Non-carious Cervical Lesions: Double-blind Randomized Clinical Trial

The aim of this study will be to evaluate the effect of prolonging solvent evaporation time on the 6- and 12-months clinical performance of two universal adhesive systems used as selective enamel etch (SEE).

Methods: 140 restorations will be randomly placed in 35 subjects according to the following groups: SUP5 (Scotchbond Universal Plus evaporated for 5 s); SUP25 (Scotchbond Universal Plus evaporated for 25 s); GBU5 (Gluma Bond Universal evaporated for 5 s); GBU25 (Gluma Bond Universal evaporated for 25 s). Resin composite will be placed incrementally and light-cured. The restorations will be evaluated at baseline, after a week, 6 and 12 months using the FDI and USPHS criteria. Statistical analyses will be performed using appropriate tests (α = 0.05).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a four-arm, double-blind, randomized controlled clinical trial. Experimental group 1: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations using an alcohol- and water-based solvent universal adhesive (Scotchbond Universal Plus; 3M) in the selective enamel etching strategy with evaporation of solvent for 25 seconds. Experimental group 2: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations using an acetone-based universal solvent adhesive (Gluma Universal Bond; Kulzer) in the selective enamel etching strategy with solvent evaporation for 25 seconds. Control group 1: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations, using an alcohol- and water-based universal solvent adhesive (Scotchbond Universal Plus; 3M), in the selective enamel etching strategy, with evaporation of solvent for 5 seconds. Control group 2: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations, using an acetone-based universal solvent adhesive (Gluma Universal Bond; Kulzer), in the strategy of selective enamel etching, with solvent evaporation for 5 seconds. LCNCs will be randomized to universal adhesive usage and flash-off time. All groups will be light-cured with a light-curing device (SmartLite Focus, Dentsply) with a light intensity of 855 mW/cm² for 20 seconds. Operators will restore the cervical area by applying three increments of resin (Opallis, FGM Prod. Odont.Ltda, Joinville, SC, Brazil). Each increment will light cure for 10 s at 1200 mW/cm2 (Radii Cal, SDI, Victoria, Australia). Restorations will be finished immediately with fine diamond burs (#3195F and #3195FF, KG Sorensen, Barueri, SP, Brazil) and polished with discs and polishing gums (Soflex, 3 M ESPE, St. Paul, MN, EE. UU.).

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Región Metropolitana
      • Santiago, Región Metropolitana, Chile, 7620086
        • Mario Felipe Gutiérrez Reyes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients older than 18 years.
  • Presence of at least two Non-Carious Cervical Lesions in the dental arch with a need for restorative treatment.
  • Acceptable level of oral hygiene according to the Simplified Oral Hygiene Index.
  • At least 20 teeth in function.
  • Non-Carious Cervical Lesions with a maximum of 50% of enamel margin.

Exclusion Criteria:

  • Driving difficulties that prevent adequate oral hygiene.
  • Periodontal disease.
  • Active caries lesions on the teeth included in the research.
  • Parafunctional habits.
  • Active staples of removable partial dentures on the teeth included in the research and that these are not pillars of prostheses.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group 1
35 non-carious cervical lesions (NCCL) will receive composite resin restorations in the selective enamel etching strategy.
Procedure: Evaporation time for 25 seconds
Composite resin restorations of non-carious cervical lesions will be performed with an adhesive with solvent evaporation for 25 seconds.
Other Names:
  • Evaporation time of solvent for 25 seconds
Device: alcohol/water-based universal adhesive
Composite resin restorations of non-carious cervical lesions will be performed with an alcohol/water-based universal adhesive (Scotchbond Universal Plus; 3M).
Other Names:
  • alcohol/water-based adhesive
Experimental: Experimental group 2
35 non-carious cervical lesions (NCCL) will receive composite resin restorations in the selective enamel etching strategy.
Procedure: Evaporation time for 25 seconds
Composite resin restorations of non-carious cervical lesions will be performed with an adhesive with solvent evaporation for 25 seconds.
Other Names:
  • Evaporation time of solvent for 25 seconds
Device: acetone-based universal adhesive
Composite resin restorations of non-carious cervical lesions will be performed with an acetone-based universal adhesive (Gluma Universal Bond; Kulzer).
Other Names:
  • acetone universal adhesive
Active Comparator: Control group 1
35 non-carious cervical lesions (NCCL) will receive composite resin restorations in the selective enamel etching strategy.
Device: alcohol/water-based universal adhesive
Composite resin restorations of non-carious cervical lesions will be performed with an alcohol/water-based universal adhesive (Scotchbond Universal Plus; 3M).
Other Names:
  • alcohol/water-based adhesive
Procedure: Evaporation time for 5 seconds
Composite resin restorations of non-carious cervical lesions will be performed with an adhesive with solvent evaporation for 5 seconds.
Other Names:
  • Evaporation time of solvent for 5 seconds
Active Comparator: Control group 2
35 non-carious cervical lesions (NCCL) will receive composite resin restorations in the selective enamel etching strategy.
Device: acetone-based universal adhesive
Composite resin restorations of non-carious cervical lesions will be performed with an acetone-based universal adhesive (Gluma Universal Bond; Kulzer).
Other Names:
  • acetone universal adhesive
Procedure: Evaporation time for 5 seconds
Composite resin restorations of non-carious cervical lesions will be performed with an adhesive with solvent evaporation for 5 seconds.
Other Names:
  • Evaporation time of solvent for 5 seconds

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention of restorations
Time Frame: From date of randomization until twenty four months

Retention measured by World Dental Federation (FDI) criteria as following:

  • VG: Clinically very good - Restoration retained, no fractures / cracks;
  • G: Clinically good - Small hairline crack;
  • SS: Clinically sufficient/satisfactory - Two or more or larger hairline cracks and/or chipping (not affecting the marginal integrity);
  • US: Clinically unsatisfactory - Chipping fractures which damage marginal quality; bulk fractures with or without partial loss (less than half of the restoration);
  • PO: Clinically poor - (Partial or complete) loss of restoration, (replacement necessary).
From date of randomization until twenty four months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Marginal Adaptation of restorations
Time Frame: From date of randomization until twenty four months

Marginal Adaptation measured by World Dental Federation (FDI) criteria as following:

  • VG: Clinically very good - Harmonious outline, no gaps, no discoloration;
  • G: Clinically good - Small marginal fracture removable by polishing;
  • SS: Clinically sufficient/satisfactory - Several small enamel or dentin fractures;
  • US: Clinically unsatisfactory - Notable enamel or dentine wall fracture;
  • PO: Clinically poor - Filling is loose but in situ.
From date of randomization until twenty four months
Marginal Staining of restorations
Time Frame: From date of randomization until twenty four months

Marginal Staining measured by World Dental Federation (FDI) criteria as following:

  • VG: Clinically very good - No marginal staining;
  • G: Clinically good - Minor marginal staining, easily removable by polishing;
  • SS: Clinically sufficient/satisfactory - Moderate marginal staining, not esthetically unacceptable;
  • US: Clinically unsatisfactory - Pronounced marginal staining; major intervention necessary for improvement;
  • PO: Clinically poor - Deep marginal staining not accessible for intervention
From date of randomization until twenty four months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de los Andes, Chile

Collaborators

Agencia Nacional de Investigación y Desarrollo

Investigators

  • Study Director: Mario Felipe Gutiérrez Reyes, PhD, Universidad de los Andes, Chile

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2023

Primary Completion (Actual)

June 23, 2023

Study Completion (Actual)

June 23, 2023

Study Registration Dates

First Submitted

June 12, 2023

First Submitted That Met QC Criteria

July 11, 2023

First Posted (Actual)

July 14, 2023

Study Record Updates

Last Update Posted (Actual)

July 14, 2023

Last Update Submitted That Met QC Criteria

July 11, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEC2022129

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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